Senior Investigator in Pharmacokinetics Sciences

Senior Investigator in Pharmacokinetics Sciences
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D.

Leads the PK Sciences strategy and influences project strategy during discovery and/or clinical program. Collaborates within the cross-functional team to identify and mitigate key project issues related to the PK Sciences discipline (PK, PK/PD, IG, metabolism and clinical pharmacology).

1. Independently represents PK Sciences a core member of discovery, translational medicine and global project teams.
2. Participates or leads PKS sub-team to define PKS strategy for compound progression and development.
3. Manages study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools.
4. Responsible for the timely and effective communication of data, strategy, results, impact to the project teams.
5. Aligns plans and strategies with sub-teams, project teams, manager and leadership team.
6. Analyze and interpret PK/TK/PD/IG data generated during discovery, early and full development; present results to the program.
7. Proactively identifies potential project hurdles, provides solutions and contributes to contingency plans.
8. Independently authors and prepares key pre-clinical and clinical, and regulatory documents including, but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
9. Actively participates in cross-departmental teams, department-wide initiatives and work streams.
10. Provide PK Sciences expertise on due diligence and prepare appropriate documentation.
11. Publishes internally or externally as main contributor to enhance Novartis and PK Sciences visibility.
12. May mentor and train other PK Science Associates.
13. Completes all required organizational trainings and requirements according to corporate timelines
14. Adhere in strict accord to the appropriate SOP and GxP guidelines.
- PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground.
- Fluent English (oral and written)

1. 8 + years of experience in drug discovery, development or a relevant environment (e.g. Clinical Pharmacology or Drug Metabolism and Pharmacokinetics).
2. Extensive and in-depth knowledge of scientific discipline specially in drug metabolism and pharmacokinetics.
3. Demonstrated success of working in cross functional project teams (preferably global) and sound awareness of recent developments in drug development sciences.
4. Knowledge of regulatory requirements and experience in dealing with regulatory authorities.
5. Proficient with full range of techniques used in job and core area.
6. Extensive library research skills.
7. Working knowledge of tools and processes used in drug design and development.
8. Sound and robust list of scientific publications.
Translational Medicine
Novartis Pharma AG
Research & Development
Full Time